Musculosketal Tumor Section, Department of Orthopedic Surgery, Copenhagen University Hospital - Rigshospitalet, Inge Lehmanns Vej 6, 2100, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Trials. 2023 Mar 18;24(1):204. doi: 10.1186/s13063-023-07237-9.
Patients receiving total hip arthroplasty (THA) due to metastatic bone disease of the hip (MBD) are at an increased risk of post-operative joint dislocation compared to other populations. Different joint solutions have been developed with the purpose of reducing the dislocation risk compared to regular THAs. One of these solutions, the constrained liner (CL), has been used increasingly at our department in recent years. This design, however, is prone to polyethylene wear and higher revision rates. An alternative is the dual mobility cup (DM), which has been shown to reduce the risk of dislocation in other high-risk populations. Few studies have investigated DM for THA due to MBD, and no studies have directly compared these two treatments in this population. We therefore decided to conduct a trial to investigate whether DM is non-inferior to CL regarding the post-operative joint dislocation risk in patients receiving THA due to MBD.
This study is a single-center, randomized, open-label, two-arm, non-inferiority trial. We will include 146 patients with MBD of the hip who are planned for THA at the Department of Orthopedic Surgery, Rigshospitalet. Patients with previous osteosynthesis or endoprosthetic surgery of the afflicted hip, or who are planned to receive partial pelvic reconstruction or total femoral replacement, will be excluded. Patients will be stratified by whether subtrochanteric bone resection will be performed and allocated to either CL or DM in a 1:1 ratio. The primary outcome is the 6 months post-operative joint dislocation rate. Secondary outcomes include overall survival, implant survival, the rate of other surgical- and post-operative complications, and quality of life and functional outcome scores.
This study is designed to investigate whether DM is non-inferior to CL regarding the risk of post-operative dislocation in patients receiving THA due to MBD. To our knowledge, this trial is the first of its kind. Knowledge gained from this trial will help guide surgeons in choosing a joint solution that minimizes the risk of dislocation and, ultimately, reduces the need for repeat surgeries in this patient population.
ClinicalTrials.gov Identifier: NCT05461313. Registered on July 15 2022. This trial is reported according to the items in the WHO Trial Registration Data Set (Version 1.3.1).
与其他人群相比，因髋关节转移性骨病（MBD）而行全髋关节置换术（THA）的患者术后关节脱位风险增加。为降低脱位风险，已开发出不同的关节解决方案，其中一种解决方案为限制衬垫（CL），近年来我院科室已越来越多地使用这种解决方案。然而，这种设计容易导致聚乙烯磨损和更高的翻修率。另一种解决方案是双动杯（DM），在其他高危人群中已证明可降低脱位风险。很少有研究调查 DM 在 MBD 所致 THA 中的应用，也没有研究直接比较这两种治疗方法在该人群中的应用。因此，我们决定开展一项试验，以调查 DM 在 MBD 所致 THA 患者中的术后关节脱位风险是否不劣于 CL。
本研究为单中心、随机、开放标签、双臂、非劣效性试验。我们将纳入 146 例因 MBD 而计划在骨科矫形外科 Rigshospitalet 行 THA 的患者。有既往受累髋关节骨内固定术或假体手术史，或计划行骨盆部分重建或全股骨置换的患者将被排除。根据是否行转子下骨切除术对患者进行分层，并按 1:1 比例分配至 CL 或 DM。主要结局为术后 6 个月关节脱位率。次要结局包括总生存率、植入物生存率、其他手术和术后并发症发生率，以及生活质量和功能结局评分。
本研究旨在调查 DM 在 MBD 所致 THA 患者中的术后脱位风险是否不劣于 CL。据我们所知，这是同类研究中的首例。该试验获得的知识将有助于指导外科医生选择一种关节解决方案，最大限度地降低脱位风险，最终减少该患者人群中重复手术的需求。
ClinicalTrials.gov 标识符：NCT05461313。2022 年 7 月 15 日注册。本试验根据世界卫生组织（WHO）临床试验注册数据集中的项目进行报告（版本 1.3.1）。
